| Primary Device ID | 00195291003776 |
| NIH Device Record Key | 181db036-2257-4c34-a88d-92771673e21c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | B/A |
| Version Model Number | 50-L3-8L-V |
| Company DUNS | 028853567 |
| Company Name | Flexmedics |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM | |
| Phone | 317-346-6655 |
| ORDER@GHORTHO.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195291003776 [Unit of Use] |
| GS1 | 10195291003773 [Primary] |
| NJM | Bracket, Ceramic, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-07-26 |
| Device Publish Date | 2020-05-27 |
| 00195291000010 - N/A | 2023-07-26 CIM CERAMIC TWIN ROTH .022 L1/2 0°T 0°A |
| 00195291000027 - N/A | 2023-07-26 CIM CERAMIC TWIN ROTH .018 L1/2 0°T 0°A |
| 00195291000232 - N/A | 2023-07-26 CIM CERAMIC TWIN ROTH .022 UL3 HK 0°T +11°A 4°R |
| 00195291000294 - N/A | 2023-07-26 CIM CERAMIC TWIN ROTH .018 UL4/5 HK -7°T 0°A |
| 10195291000314 - N/A | 2023-07-26 CIM CERAMIC TWIN ROTH .018 HK/345 W/CASE |
| 00195291000416 - N/A | 2023-07-26 CIM CERAMIC TWIN MBT .018 LL4 HK -12°T 0°A |
| 00195291000614 - N/A | 2023-07-26 CIM CERAMIC TWIN MBT .018 UL4/5 HK -7°T 0°A |
| 00195291000652 - N/A | 2023-07-26 CIM Ceramic Twin ROTH .022 L1/2 0°T 0°A |